CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Latarjet Experience Sharp Curved Ostetome recalled

DePuy Mitek, Inc., a Johnson & Johnson is recalling Latarjet Experience Sharp Curved Ostetome, distributed nationwide in the US. The recall was initiated on 22 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes16D01,16D02, 16K01, 17A01, 17B01, 17B02

Quantity recalled84

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1749-2018
FDA event ID: 79518
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 22 Dec 2017
FDA classified: 8 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Hip & Knee Implants

Timeline

22 Dec 2017	Recall initiated by company
8 May 2018	Classified by FDA	+137 days
16 May 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reports of product loosening or coming unscrewed from the handle.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.

Where it was distributed

US Nationwide Distribution in the states of OH, WA, CO

Nationwide Colorado Washington

Questions about this recall

Why was it recalled?

Reports of product loosening or coming unscrewed from the handle.

Which lots are affected?

16D01,16D02, 16K01, 17A01, 17B01, 17B02

Where was it sold?

US Nationwide Distribution in the states of OH, WA, CO

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from DePuy Mitek, Inc., a Johnson & Johnson

All 51

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025Device	CLASS II	COR Disposable Kit w/ Perpendicularity recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
19 Mar 2025Device	CLASS II	COR Disposable Kit Cartilage Transplant System recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Rapid w/ Pan-Indicated for use recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Plus w/ Ethibond-Iindicated recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Rapid W/ OC-Indicated for use recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide

Other Hip & Knee Implants recalls

All 3,111

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Intellijoint Navigation System: Workstation G2 Configured recalled	Intellijoint Surgical	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled	New York Embroidery Studio	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide